First Responder Resiliency Program During COVID-19

NCT ID: NCT04536376

Last Updated: 2024-05-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2022-12-31

Brief Summary

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Evaluating a wellness program developed to provide effective sustainable solutions for medical professionals providing care to COVID-19 pandemic patients.

Detailed Description

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Providing mindfulness training at specific time points during study participation with an emphasis on integrating physical and mental health management. The phase-based program delivers individualized, data-driven and quantifiable solutions that directly address pain points impacting healthcare professionals and organizations.

Conditions

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Resilience Stress Sleep

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Resilience Program

a 4 week program focused on improving resilience

Group Type EXPERIMENTAL

Resilience Program

Intervention Type BEHAVIORAL

Subjects receive program devices, and will be asked to wear during rest and sleep on a nightly basis along with active use during daytime. Notifications are sent daily, individualized approach developed and sent to participants to participate on.

Interventions

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Resilience Program

Subjects receive program devices, and will be asked to wear during rest and sleep on a nightly basis along with active use during daytime. Notifications are sent daily, individualized approach developed and sent to participants to participate on.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. 18 years of age or older at the time of consent
2. Frontline healthcare professional
3. Have access to an Apple or Android device
4. Not pregnant by subject self-report at time of consent
5. Have the ability to provide informed consent
6. Have no contraindicating comorbid health condition as determined by the clinical investigators

Exclusion Criteria

1. Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis
2. Currently (within the past 3 weeks) been undergoing an additional program (e.g. CAM) to improve quality of life or sleep
3. Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, stress or sleep
4. An unstable medical or mental health condition as determined by the physician investigator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PNMedical

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ivana T Croghan, PhD

Professor of Medicine, College of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivana T Croghan, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Brent Bauer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Croghan IT, Hurt RT, Fokken SC, Fischer KM, Lindeen SA, Schroeder DR, Ganesh R, Ghosh K, Bausek N, Bauer BA. Stress Resilience Program for Health Care Professionals During a Pandemic: A Pilot Program. Workplace Health Saf. 2023 Apr;71(4):173-180. doi: 10.1177/21650799221093775. Epub 2022 Jul 5.

Reference Type RESULT
PMID: 35787711 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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20-005017

Identifier Type: -

Identifier Source: org_study_id

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